IRB HANDBOOK April 2010

Transcription

1 IRB HANDBOOK April 2010

2 Table of Contents Section 1: Introduction... 1 A. Authority A-1. By what authority does Harding University s Institutional Review Board (IRB) function? 1.A-2. What are the overarching responsibilities that come with this authority? 1.A-3. What document guides this manual? B. Dedication to Christian Principles B-1. How is Harding committed to Christian principles? 1.B-2. How does Harding integrate this commitment into the function of the IRB? 1.B-3. What goals does the Harding IRB strive to uphold? Section 2: Structure of the IRB... 3 A. Membership Qualifications A.1 What is the foundation for the IRB membership policy of Harding? 2-A.2. What are the general qualifications for membership in the Harding IRB? 2-A.3. What are the specific qualifications for a member of the Harding IRB? B. Recruitment and Identification of Prospective Members B.1. How are prospective members recruited and identified? 2-B.2. What is the application process for prospective members? C. Evaluation and Appointment of Prospective Members C.1. What is the process for evaluating applications? 2-C.2. What criteria will be used to evaluate the applications? 2-C.3. What is the length of an appointment? D. Designated Officers D.1. How is the IRB chairperson selected? 2-D.2. Is a Board secretary needed? E. Conflict of Interest E.1. What might present a conflict of interest to an IRB member? Section 3: Functions of the IRB... 8 A. Board Meetings A.1. What is the purpose of IRB meetings? 3-A.2. When are Board meetings held? 3-A.3. What are the requirements for Board meetings? Harding University Institutional Review Board (IRB) Manual i

3 B. Reviewing Proposals B.1. What authority does the IRB have? 3-B.2. How does the review process work? 3-B.3. What are the criteria by which a proposal must be judged? 3-B.4. Can the board modify these requirements on any proposed project? 3-B.5. What actions can the Board take on submitted proposals? 3-B.6. What is the process for appealing a Board decision? 3.B-7. Can projects approved by the IRB also be reviewed by other Harding officials? C. Expedited Review C.1. What is expedited review? 3-C.2. What is the process for expedited review for a project proposal? 3-C.3. What is the process for expedited review for a project amendment? 3-C.4. What is the process for expedited review regarding information submitted as a result of conditional project approval? 3-C.5. What sorts of projects qualify for expedited review? D. Requests for Exemptions D.1. What is the process for requesting an exemption? 3-D.2. Which proposals might be exempt from IRB review? 3-D.3. What is the safest way to ascertain whether a proposal may be exempt from IRB review? E. Continuing Review E.1. What is continuing review? 3-E.2. What is the process for continuing review? F. Suspension or Termination of Approved Projects F.1. Under what conditions can the IRB suspend or terminate an approved project? 3-F.2. What are the consequences for the suspension or termination of a project? Section 4: Research Requirements A. Certification of Researcher Training A-1. What training is required before a research proposal may be submitted? 4.A-2. Who is required to complete such training? B. Research Requiring IRB Review B-1. For the purposes of IRB review, what is the definition of the term research? 4.B-2. What research must receive IRB approval prior to any data collection? 4.B-3. For the purposes of IRB review, what is the definition of the term human subject? 4.B-4. For the purposes of IRB review, what is meant by intervention? 4.B-5. For the purposes of IRB review, what is meant by interaction? 4.B-6. For the purposes of IRB review, what is meant by private information? 4.B-7. Under what circumstances do these requirements apply?

4 C. Research Exempt from IRB Review C-1. Are there any research projects that may be exempt from IRB review? 4-C.2. What is the safest way to determine whether a proposal may be exempt from IRB review? 4-C.3. What is the process for requesting an exemption? D. Special Cases D-1. What are considered special cases and what are the associated requirements? 4.D-2. Who is obligated to comply with the federal regulations regarding special cases? E. Proposal Submission E.1. What is the process for submitting a proposal for review? 4-E.2. By what criteria will a proposal be evaluated? 4-E.3. What documentation is needed for a complete application? 4-E.4. What is the request for review process when the research is a cooperative project involving other institutions in addition to Harding? F. Informed Consent F.1. What are the general requirements for informed consent? 4-F.2. What information must be provided to subjects to ensure compliance with informed consent requirements? 4-F.3. How should informed consent be documented? 4-F.4. For the purpose of these requirements, what is meant by minimal risk? 4-F.5. Is there anything else to know regarding informed consent? G. Expedited Review G.1. What is expedited review? 4-G.2. What is the process for requesting expedited review for a project proposal? 4-G.3. What sorts of projects qualify for expedited review? H. Approval Process H.1. What is the process by which the IRB reviews and decides on requests? 4-H.2. What can I do if my request is denied? I. Amendments to Approved Research I.1. What is the process amending an approved plan? 4-I.2. What if a research study initially does not involve human subjects but the researchers decide to include them at a later date? J. Animal Welfare J.1. What are the requirements regarding the use of animals for research purposes? Section 5: Administrative Support for the IRB A. Role of the IRB Administrator A-1. What is the role of the IRB administrator with regard to the IRB? 5.A-2. What is the role of the IRB administrator with regard to researchers?

5 5.A-3. What is the role of the IRB administrator with regard to the VPAA? 5.A-4. What is the chain of command for the administrator and administrative staff? 5.A-5. Where does administrative support for the IRB fall within Harding s organizational framework? B. Administrator and Staff Qualifications B-1. What are the professional requirements for the IRB administrator and staff? C. Responsibilities Regarding IRB Meetings C-1. What are the responsibilities of the administrator regarding IRB meetings? D. Administrative Responsibilities D-1. What is the role of the administrator and staff with regard to communication? 5.D-2. What is the role of the administrator and staff with regard to the identification, recruitment, and appointment of potential Board members? 5.D-3. What is the role of the administrator and staff with regard to items pending Board review? 5.D-4. What is the role of the administrator and staff with regard to approved projects? E. Record Keeping E-1. What is the role of the administrator and staff with regard to record keeping? 5.E-2. How long must such records be archived? Appendices A. Schedule of Board Meetings B. Forms B-1: Researcher Forms Request for Exemption from IRB Review Request for Expedited Review Request for Research Review Request for Appeal Request for Amendment to Approved Research Request for Project Continuation B-2: Board Forms Status of Request for Exemption from IRB Review Status of Request for Expedited Review Status of Research Review Status of Request for Appeal Status of Request for Amendment to Approved Research Status of Request for Project Continuation C. Projects that Qualify for Expedited Review D. Projects that Qualify for Exemption E. IRB Member Application F. Confidentiality Agreement... 57

6 Section 1 Introduction A. Authority B. Dedication to Christian Principles A. Authority 1.A-1. By what authority does Harding University s Institutional Review Board (IRB) function? a. Harding University s IRB is formally designated to review and monitor biomedical, social science, psychological, psychosocial, ethnographic, and other research involving human subjects and is the sole entity authorized to issue IRB approval for Harding University [ (g-h); (a)]. b. The Harding University IRB functions as the institution s decisionmaking body on all issues related to human subject research [ (a)(2); (c-e); (a)]. c. Harding University s IRB functions in compliance with: 1. Federal law as set forth in 5 U.S.C. 301; 42 U.S.C. 289(a), and 2. Federal regulations as set forth in Department Of Health And Human Services Title 45: Public Welfare, Part 46, Human Subjects: Protection Of Human Subjects, revised June 23, A-2. What are the overarching responsibilities that come with this authority? a. Harding University recognizes that compliance with the federal policy requires adherence to pertinent federal laws or regulations which provide additional protections for human subjects [ (e)]. b. This policy does not affect any state or local laws or regulations which may otherwise be applicable and which provide additional protections for human subjects [ (f)]. c. The Harding IRB will address (1) all proposals initiated by faculty and staff at Harding University, Harding Academy, or Harding Place, and (2) proposals initiated by other institutions that request data from Harding University, Harding Academy, or Harding Place.. 1.A-3. What document guides this manual? a. The document used to describe terms, policies, and procedures relating to Harding s IRB is the federal regulatory document identified in 1.A-1(c)(2) of this manual. 1

7 b. Terms, policies, and practices stated in this manual that are required by federal law and regulation are followed by a notation [set in brackets] designating the section of federal regulations being referenced. B. Dedication to Christian Principles 1.B-1. How is Harding committed to Christian principles? a. The mission of Harding University is to provide a quality education that will lead to an understanding and philosophy of life consistent with Christian ideals. 1.B-2. How does Harding integrate this commitment into the function of the IRB? a. Harding University acknowledges and affirms the sanctity and dignity of human beings created in the image of God. Therefore, the Institutional Review Board (IRB), which is responsible to guard and protect the rights and well-being of human subjects, will ensure compliance with the established federal and university procedural and ethical guidelines [ (b)(1)]. 1. B-3. What goals does the Harding IRB strive to uphold? a. Compliance with federal law and guidelines [5 U.S.C. 301; 42 U.S.C. 289(a), and Title 45: Public Welfare, Part 46, Human Subjects: Protection Of Human Subjects, revised June 23, 2005] (Romans 13:1-5; Titus 3:1; I Peter 2:13-14). b. The integration of faith, learning, and living, as evidenced by a commitment to Christ and to the Bible as the Word of God and the encouragement of Christian service through a servant-leadership lifestyle (Matthew 20:28; Mark 10:45; Luke 4:8; Ephesians 6:7). c. The development of Christian scholarship, as evidenced by maintaining a Christian commitment to intellectual excellence, ethics, and effective professional preparation (Matthew 25:14-29; Matthew 25:40). d. The promotion of Christian ethics, as evidenced by uncompromising professional integrity and a sincere commitment to the well-being of God s creation (Genesis 2:15; Proverbs 29:7; Matthew 25:40; Matthew 25:45; Luke 7:28; Luke 9:48). 2

8 Section 2 Structure of the IRB A. Membership Qualifications B. Recruitment and Identification of Prospective Members C. Evaluation and Appointment of Prospective Members D. Designated Officers E. Conflict of Interest A. Membership Qualifications 2-A.1 What is the foundation for the IRB membership policy of Harding? a. Harding University s IRB membership is a privilege and a responsibility granted by invitation to scientific and non-scientific members of the community. The membership policy of the Harding University IRB is consistent with federal law and regulations [ ]. 2-A.2. What are the general qualifications for membership in the Harding IRB? a. Membership must include individuals with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through: (i) the experience and expertise of its members, (ii) the diversity of its members, including consideration of race, gender, and cultural backgrounds, (iii) the local nature of its members, providing sensitivity to such issues as community attitudes, and (iv) the professionalism of its members, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects [ (a)]. b. Members must be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas [ (a)]. c. Members must have completed required training before being appointed. Harding requires all IRB members to successfully complete online training offered by the National Institute of Health (NIH). Certificates of completion must be kept on file in the IRB office. 3

9 2-A.3. What are the specific qualifications for a member of the Harding IRB? a. The IRB will be comprised of no more than 9 members, including members who meet the following characteristics: 1. A licensed physician (due to regular reviews of research involving children) [ (a)]. 2. A person whose primary concerns are in nonscientific areas [ (c)]. 3. A person who is not affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution [ (d)]. 4. An attorney familiar with applicable law and standards of professional conduct and practice. 5. A person whose primary concerns are in scientific areas [ (c)]. 6. Representatives from the colleges and programs at Harding. b. The IRB may not consist entirely of members of one profession [ (b)]. c. The IRB will not include more than three members from within any college of the university. d. The IRB shall be balanced in terms of men and women, but no selection can be made to the IRB on the basis of gender alone [ (b)]. e. The IRB chairperson may, in his or her discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB [ (f)]. B. Recruitment and Identification of Prospective Members 2-B.1. How are prospective members recruited and identified? a. Prospective members will be sought through one or more of the following means: 1. Recommendations from current IRB members or staff. 2. Recommendations from other research professionals or IRBs. 3. Advertisements. 4

10 4. Recommendations from research institutions, research sites, or community organizations. 5. Other means as recommended by the IRB administrator and approved by the IRB chairperson. b. Prospective members, once identified by the IRB Board or IRB administrator, will be contacted and instructed regarding the application process in accordance with 2-B.2 (below). c. Non-solicited individuals may submit applications. 2-B.2. What is the application process for prospective members? a. All prospective members will be required to complete and submit the following documents as one package: 1. An Application for IRB Membership (Appendix E). 2. A current, dated CV or resume. 3. A copy of NIH training certification, as described in 2-A.2(c). 4. A copy of any professional license (if applicable). 5. A signed Confidentiality Agreement (Appendix F). b. Completed applications and supporting documents must be submitted to the IRB administrator for initial processing. c. Prospective members may attend one IRB meeting, without voting, by invitation only, after signing the Confidentiality Agreement (Appendix F). C. Evaluation and Appointment of Prospective Members 2-C.1. What is the process for evaluating applications? a. The applications of prospective candidates must be reviewed by the IRB administrator to ensure that all required documents have been submitted. b. The IRB administrator provides documents to Board members prior to their scheduled meeting according to the timeline outlined in Appendix A. c. At the IRB meeting, members vote on the candidates and list them in priority order. d. The list is submitted to the Vice President of Academic Affairs (VPAA). e. The VPAA will appoint IRB members from this list. 5

11 f. Upon notification of the VPAA s selection, the IRB Administrator will prepare a letter of appointment for the new member and present it to the VPAA for signature. g. Once signed by the VPAA, the IRB administrator will forward the original letter to the member, notify IRB members, and add the letter to the member s file. h. The new member s name will be added to the IRB Roster and a modification to the IRB registration with the Office for Human Research Protections (OHRP) will be made. 2-C.2. What criteria will be used to evaluate the applications? a. All prospective applicants will be evaluated for potential membership on criteria which may include, but is not limited to, the following: 1. Evidence of education and training (as documented in the applicant s CV). 2. Community service. 3. Length of residence in the community. 4. Specific needs of the IRB. 5. Willingness and time to serve their term. 6. Other criteria as decided upon by the IRB. 2-C.3. What is the length of an appointment? D. Designated Officers a. Appointees will serve an initial three-year term and may be reappointed by the VPAA to successive three-year terms. b. For the purposes of establishing a rotation of members, in August 2009 the VPAA shall appoint 9 members to the board who shall then conduct a lottery at the September 2009 meeting to determine which three members shall serve a one-year term, which three members shall serve a two-year term, and which three members shall serve a three-year term. 2-D.1. How is the IRB chairperson selected? a. The IRB chairperson is appointed by the VPAA from among existing board members. 2-D.2. Is a Board secretary needed? a. The Board may elect a secretary whose responsibility will be to record the proceedings of all meetings in written format, or the 6

12 Board may designate that responsibility to the IRB administrator in accordance with 5.C-1(c)(3) of this manual. E. Conflict of Interest 2-E.1. What might present a conflict of interest to an IRB member? a. No member of the Harding IRB may be a part of initial or continuing review of any project in which the member has a role or other interest, except to provide information requested by the IRB [ (e)]. b. In such instances, the Board member must recuse himself from any participation in IRB actions regarding the project. 7

13 Section 3 Functions of the IRB A. Board Meetings B. Reviewing Proposals C. Expedited Review D. Requests for Exemptions E. Continuing Review F. Suspension or Termination of Approved Projects A. Board Meetings 3-A.1. What is the purpose of IRB meetings? a. The primary purpose of board meetings will be to review, evaluate, and take action on research proposals. b. Other actions may include but are not limited to consideration of requests for amendments to existing projects, requests for exemptions, requests for continuing review, appeals, and other issues. c. Administrative issues such as the review and revision of IRB policies shall be addressed at IRB meetings on an as-needs basis. 1. Policy revisions may be made no more than once per year, unless federal regulations require changes or a majority of the Board votes to permit consideration of such changes. 2. Policies may be changed only upon a majority vote of the board. 3. Changes to policy must be communicated to those who will be impacted by such changes. 3-A.2. When are Board meetings held? a. A minimum of eight board meetings must be scheduled during the school year, with an additional meeting to take place during the summer if the need arises. b. Board meetings shall be scheduled on the second Wednesday of select months. (For the current schedule, see Appendix A of this manual.) 8

14 c. Scheduled board meetings may be cancelled when no proposals have been submitted for review. 3-A.3. What are the requirements for Board meetings? a. The Board shall follow all written policies and procedures as required by federal regulations [ (b)(4); (b)(5); (a)]. b. Except when an expedited review process in accordance with 3-C is used [ (b)], the Board may convene with fewer than a majority of board members present, but a majority of members, including at least one member whose primary concerns are in a nonscientific area, must be present for the board to review and take action on such requests as listed below [ (b)]: 1. Request for Exemption from IRB Review 2. Request for Research Review 3. Request for Appeal 4. Request for Amendment to Approved Research 5. Request for Project Continuation c. Any Board member who has a conflicting interest in a project that is up for initial or continuing review or for approval to amendments must recuse himself/herself from any and all deliberations and voting. However, the member may provide information requested by the IRB [ (e)]. d. The Board, at its discretion, may invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB [ (f)]. e. The Board chairperson shall direct the IRB administrator or Board secretary to ensure that meeting minutes are recorded in written form at all meetings in accordance with the requirements outlined in 5.E-1-2 of this manual [ (a)]. B. Reviewing Proposals 3-B.1. What authority does the IRB have? a. The Board shall have authority to approve, require modifications to, or disapprove all research activities covered by this policy [ (a)]. 9

15 b. In order for a request requiring a full IRB review [ 3-A.3(b)] to be approved, it shall receive the official approval of a majority of those members present at the meeting [ (c)]. c. Requests for expedited review require only the review and signature of the IRB chairperson, in accordance with 3.C.1(b-c). 3-B.2. How does the review process work? a. The principal investigator completes a Request for Research Review form and submits it to the IRB administrator a minimum of 30 days before the Board meeting. Requests submitted in fewer than 30 days before a Board meeting may be reviewed at a future meeting. b. The IRB administrator communicates regularly with the IRB chairperson regarding any review requests. c. The IRB administrator delivers to Board members copies of all proposals scheduled for consideration approximately 6-10 business days prior to the meeting, in accordance with the requirements in Appendix A. d. Board members are expected to have reviewed all materials before the Board meets. e. When the Board convenes, each proposal is discussed and one of four actions is taken, in accordance with 3-B.5(a) of this manual. f. When there are no proposals to be reviewed, IRB members will be notified approximately business days prior to a meeting that the meeting is cancelled. 3-B.3. What are the criteria by which a proposal must be judged? a. All of the following requirements must be satisfied for a proposal to receive IRB approval [ ]: 1. Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes [ (a)(1)]. 2. Risks to subjects are reasonable in relation to (i) anticipated benefits (if any) to subjects, and (ii) the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The 10

16 IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility [ (a)(2)]. 3. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant if the research involves vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons [ (a)(3)]. 4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, 4-F.1-5 of this manual [ (a)(4)]. 5. Informed consent will be appropriately documented, in accordance with, and to the extent required by, 4-F.3 of this manual [ (a)(5)]. 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects [ (a)(6)]. 7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data [ (a)(7)]. 8. Any other reasonable criteria that the IRB may deem necessary to maintain the safety of subjects and the integrity of the institution. b. When any of the subjects are children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study, as outlined in 4.D.1-2 of this manual, to protect the rights and welfare of these subjects [ (b)]. c. Approval may be given to a consent procedure which does not include, or which alters, some or all of the elements of informed consent outlined in 4-F.1-5 of this manual, provided that there is documentation that: 1. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or 11

17 procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs [ (b)(5)]; and 2. The research could not practicably be carried out without the waiver or alteration of the informed consent requirements; however, safety and confidentiality must still be ensured [ (c)]. 3-B.4. Can the board modify these requirements on any proposed project? a. The IRB may impose additional conditions prior to or at the time of approval when, in the judgment of the IRB, additional conditions are necessary for the protection of human subjects [ ]. b. In limited cases, the Board may waive documentation of informed consent for some or all subjects [ (c); (c)]: 1. In the event that the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality, then each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern [ (c)(1)]; or 2. In the event that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context [ (c)(2)]. 3. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research [ (c)(2)]. 3-B.5. What actions can the Board take on proposals submitted for review? a. The IRB must take one of the following actions regarding such proposals: 1. Approve. Researchers whose proposals are approved may begin their treatments and data collection immediately. The Board shall notify investigators in writing regarding its decision by issuing a Status of Research Review form [ (h); (d)]. In this case the research project is considered certified [ (j)]. 2. Conditional approval. Researchers whose proposals receive conditional approval have 30 days in which to file a 12

18 Request for Amendment to Approved Research form. If the modifications are approved, a Status of Request for Amendment to Approved Research form will be issued. This may be done on an expedited basis. 3. Request for further information. At its discretion, the Board may request additional information. 4. Disapprove. If the Board disapproves a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond [ (d)]. If the principal investigator disagrees with the decision of the Board, he or she shall have 20 business days in which to make an appeal to the Board by submitting a Request for Appeal form to the IRB administrator. b. All decisions of the Board must be communicated to the Office of the Vice President for Academic Affairs (VPAA). 3-B.6. What is the process for appealing a Board decision? a. The principal investigator has 20 business days in which to complete a Request for Appeal form and submit it to the IRB administrator. b. Appeals must be placed on the agenda for the first Board meeting following the decision to disapprove. The Board will consider the appeal and issue one of three rulings on the Status of Request for Appeal form: 1. Appeal is granted and the project may proceed. 2. Appeal is conditionally granted and project may proceed with modifications. A Request for Amendment to Approved Research form must be filed within 30 days of this ruling and must be considered at the next meeting of the Board before full approval will be granted. 3. Appeal is denied. c. With regard to appeals, the decision of the Board is final. d. All decisions of the Board must be communicated to the Office of the VPAA. 3.B-7. Can projects approved by the IRB also be reviewed by other Harding officials? a. Yes. Approved projects may be subject to further appropriate review and approval or disapproval by Harding officials. 13

19 However, those officials may not approve the research if it has not been approved by the IRB [ ]. C. Expedited Review 3-C.1. What is expedited review? a. Expedited review is a process whereby certain issues may forgo a review by the full Board. Such issues may include but are not limited to: 1. Request for Exemption from IRB Review 2. Request for Research Review 3. Request for Amendment to Approved Research 4. Request for Project Continuation b. Under an expedited review procedure, the review may be conducted by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB [ (b)(2)]. c. In reviewing the research, the reviewer(s) may exercise all of the authorities of the IRB except that the reviewer(s) may not disapprove the research [ (b)(2)]. 1. A research activity may be disapproved only after review by the Board in accordance with the standard non-expedited procedure set forth in 3-B of this manual (above) [ (b)(2)]. 3-C.2. What is the process for expedited review for a project proposal? a. The principal investigator must complete a Request for Expedited Review form and submit it to the IRB administrator, along with the project proposal. b. The IRB administrator will document receipt of the request and forward it to the IRB chairperson. c. The IRB chairperson will review the request and determine if it meets the qualifications for expedited review [ (b)(1)]. He or she may take one of two actions: 1. Approve the request and inform the investigator in writing by issuing a Status of Request for Expedited Review form. The Board chairperson will inform the Board of this decision at the next meeting [ (c)], or 14

20 2. Place the request on the agenda of the next Board meeting and inform the principal investigator of this action by letter and include the date, time, and place of this meeting. 3-C.3. What is the process for expedited review for a project amendment? a. The principal investigator must complete a Request for Amendment to Approved Research form and submit it to the IRB administrator. b. The IRB administrator will document receipt of the request and forward it to the IRB chairperson. c. The IRB chairperson will review the request and determine if it constitutes only a minor change [ (b)(2)]. He or she may take one of two actions: 1. Approve the request and inform the investigator in writing by issuing a Status of Request for Amendment to Approved Research form. The Board chairperson will inform the Board of this decision at the next meeting [ (c)], or 2. Place the request on the agenda of the next Board meeting and inform the principal investigator of this action by letter and include the date, time, and place of this meeting. 3-C.4. What is the process for expedited review regarding information submitted as a result of conditional project approval? a. The principal investigator must complete a Request for Amendment to Approved Research form and submit it to the IRB administrator. b. The IRB administrator will document receipt of the request and forward it to the IRB chairperson. c. The IRB chairperson will review the request and determine if it constitutes only a minor change [ (b)(2)]. He or she may take one of two actions: 1. Approve the request and inform the investigator in writing by issuing an Status of Request for Amendment to Approved Research form. The Board chairperson will inform the Board of this decision at the next meeting [ (c)], or 2. Place the request on the agenda of the next Board meeting and inform the principal investigator of this action by letter and include the date, time, and place of this meeting. 3-C.5. What sorts of projects qualify for expedited review? 1. A list of projects that qualify for expedited review [ (a)] can be found in Appendix C, Projects that Qualify for Expedited Review. 15

21 D. Requests for Exemptions 3-D.1. What is the process for requesting an exemption? a. The principal investigator must complete a Request for Exemption from IRB Review form and submit it to the IRB administrator. b. The IRB administrator will document receipt of the request and forward it to the IRB chairperson. c. The IRB chairperson will review the request and determine if it meets the qualifications for exemption [ (b-d)]. He or she may take one of two actions: 1. Approve the request and inform the investigator in writing by issuing a Status of Request for Exemption from IRB Review form. The Board chairperson will inform the Board of this decision at the next meeting [ (c)], or 2. Place the request on the agenda of the next Board meeting and inform the principal investigator of this action by letter and include the date, time, and place of this meeting. 3-D.2. Which proposals might be exempt from IRB review? a. A list of projects that qualify for exemptions from review can be found in Appendix D, Projects that Qualify for Exemptions [ (b-d)]. 3-D.3. What is the safest way to ascertain whether a proposal may be exempt from IRB review? a. If there is any doubt, a Request for Exemption from IRB Review form must be completed and submitted. E. Continuing Review 3-E.1. What is continuing review? a. Continuing review means that the Board must review approved projects at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research [ (e)]. 3-E.2. What is the process for continuing review? a. The IRB administrator has the responsibility for reminding a principal investigator that it is time to request continuing review. 16

22 b. A Request for Project Continuation form must be submitted by the principal investigator to the Board in time for such request to be considered and acted upon before the one-year anniversary of the project s initial approval. This action is unnecessary if the Board has formally reviewed the project anytime within that period. c. The Board may grant the authority for continuing review to the Board chairperson so as to expedite the process. d. Once a project has been reviewed, the Board or chairperson, in accordance with 3-E.2(c), will issue a Status of Request for Project Continuation form. F. Suspension or Termination of Approved Projects 3-F.1. Under what conditions can the IRB suspend or terminate an approved project? a. The IRB shall have authority to suspend or terminate approved research that is not being conducted in accordance with the requirements of the Board or that has been associated with unexpected serious harm to subjects [ (a); ]. b. Any suspension or termination of approval shall include a statement of the reasons for the action of the Board and shall be reported promptly to the investigator and VPAA [ ]. 3-F.2. What are the consequences for the suspension or termination of a project? a. The consequences may include but not be limited to: 1. Withdrawal of both direct and non-direct support from the sponsoring institution [ (a)]. 17

23 Section 4 Research Requirements A. Certification of Researcher Training B. Research Requiring IRB Review C. Research Exempt from IRB Review D. Special Cases E. Proposal Submission F. Informed Consent G. Expedited Review H. Approval Process I. Amendments to Approved Research J. Animal Welfare A. Certification of Researcher Training 4.A-1. What training is required before a research proposal may be submitted? a. Researchers must have completed mandatory training before submitting any request for project review. Harding requires successful completion of the online Human Subjects Training offered by the National Institute of Health (NIH). b. A valid certificate of Human Subjects Training must be on file in the IRB office and also submitted as a part of any IRB request. 4.A-2. Who is required to complete such training? a. All IRB members. b. The Vice President for Academic Affairs (VPAA). c. IRB administrator and staff. d. All doctoral candidates. e. All students conducting class-related or non-class related research (must be under faculty mentor). f. All non-harding persons applying to use Harding s students, faculty, staff, or administrators in their research. g. All faculty advisors requiring class-related research. h. All members of Harding University dissertation teams. 18

24 i. All faculty members not listed in 4.A-2 who are conducting research in accordance with the definition in 4.B-1 of this manual. B. Research Requiring IRB Review 4.B-1. For the purposes of IRB review, what is the definition of the term research? a. The term research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities [ (d)]. 4.B-2. What research must receive IRB approval prior to any data collection? a. Research belonging to any of categories listed in this section must comply with federal regulations, comply with Harding's policies for the protection of human subjects (see 4.B-3 below), and must be submitted to the IRB for review before interventions (see 4.B-4 below), interactions (see 4.B-5 below), or data collection are initiated: 1. Studies that use people to test devices, products, or materials that have been developed through research. 2. Studies that use people to evaluate environmental alterations. 3. Studies that collect data through intervention with individuals. Intervention includes not only physical procedures (e.g., drawing blood) but also manipulation of a subject's environment (e.g., surveys, questionnaires, interviews, and focus groups). (Data collection using non-individually identifiable information may be exempt. Only the IRB has the authority to determine exemptions.) 4. Studies that collect data through interaction with individuals. Interaction includes communication or interpersonal contact between investigator and subject. This includes all surveys. 5. Studies using private information that can be readily identified with individuals, even if the information was not collected specifically for a study. 6. Studies that use bodily materials such as cells, blood, urine, tissues, organs, hair, or nail clippings, even if the researcher 19

25 did not collect these materials. (However, such research may be considered exempt if materials are not personally identifiable. Only the IRB has the authority to determine exemptions.) 7. Studies that produce generalizable knowledge about categories or class of subjects from individually identifiable information. 4.B-3. For the purposes of IRB review, what is the definition of the term human subject? a. The term human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains: 1. Data through intervention (see 4.B-4 below) or interaction (see 4.B-5 below) with the individual [ (f)(1)], or 2. Identifiable private information [ (f)(2)] (see 4.B-6 below) 4.B-4. For the purposes of IRB review, what is meant by intervention? a. The term intervention includes: 1. Physical procedures by which data are gathered (for example, venipuncture), and 2. Manipulations of the subject or the subject's environment that are performed for research purposes [ (f)]. 4.B-5. For the purposes of IRB review, what is meant by interaction? a. The term interaction includes communication or interpersonal contact between investigator and subject [ (f)]. 4.B-6. For the purposes of IRB review, what is meant by private information? a. The term private information includes: 1. Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and 2. Information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). b. Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order to obtain 20

26 the information to constitute research involving human subjects [ (f)]. 4.B-7. Under what circumstances do these requirements apply? a. These requirements apply if the research is conducted using Harding facilities or property, supported with Harding funds, or performed by Harding faculty, staff, or students. b. Additional requirements are necessary in certain cases (see 4.D.1-2). C. Research Exempt from IRB Review 4.C-1. Are there any research projects that may be exempt from IRB review? a. A list of projects that qualify for exemptions from review is found in Appendix D, Projects that Qualify for Exemptions [ (b-d)]. 4-C.2. What is the safest way to determine whether a proposal may be exempt from IRB review? a. If there is any doubt, a Request for Exemption from IRB Review form must be completed and submitted. 4-C.3. What is the process for requesting an exemption? a. The principal investigator must complete a Request for Exemption from IRB Review form and submit it to the IRB administrator. b. The review process is outlined in 3.D.1 of this manual. D. Special Cases 4.D-1. What are considered special cases and what are the associated requirements? a. The designation special cases includes research involving specific subjects, and in all cases such research is subject to further regulation. These subjects include: 1. Pregnant women, human fetuses and neonates. [See federal regulations, Department Of Health And Human Services, Title 45, Part 46: Protection Of Human Subjects, Subpart B: ] 21

27 2. Prisoners as subjects. [See federal regulations, Department Of Health And Human Services, Title 45, Part 46: Protection Of Human Subjects, Subpart C: ] 3. Children as subjects. [See federal regulations, Department Of Health And Human Services, Title 45, Part 46: Protection Of Human Subjects, Subpart D: ] 4. Mentally disabled or or economically or educationally disadvantaged persons as subjects. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects. [See federal regulations, Department Of Health And Human Services, Title 45, Part 46: Protection Of Human Subjects, (b)]. b. The designation special cases also includes certain types of research: 1. Research conducted or supported by any federal department or agency is subject to further regulation. [See federal regulations, Department Of Health And Human Services, Title 45, Part 46: Protection Of Human Subjects, Subpart A: ]. 2. Research that takes place in foreign countries is subject to further regulation in that the IRB must determine whether the procedures prescribed by the foreign country afford protections that are at least equivalent to those provided in U.S. federal regulations. In such a case, the IRB may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. [See federal regulations, Department Of Health And Human Services, Title 45, Part 46: Protection Of Human Subjects, (g-h)]. 4.D-2. Who is obligated to comply with the federal regulations regarding special cases? a. It is the responsibility of the primary investigator to be aware of and to comply with regulations regarding special cases. 22

28 E. Proposal Submission 4-E.1. What is the process for submitting a proposal for review? a. The principal investigator completes a Request for Research Review form and submits it to the IRB administrator a minimum of 30 days before the Board meeting. Requests submitted in fewer than 30 days before a Board meeting may be reviewed at a future meeting. This process will be followed in accordance with 3-B.2 of this manual. 4-E.2. By what criteria will a proposal be evaluated? a. For information regarding evaluative criteria, see 3-B.3 in this manual. 4-E.3. What documentation is needed for a complete application? (See also Request for Research Review form located in Appendix A.) a. Documentation of human subjects training (attached or on file) b. Purpose and significance of the study c. Proposed methods and statistical analysis d. Instruments (attached: surveys, tests, interview forms/scripts, etc.) e. Database (If using database to collect data, describe the information that will be collected.) f. Subjects described including selection and recruitment procedures g. Potential risks described and the precautions taken h. Copy of cover letter(s), permission form(s), and consent form(s) [if required] i. Copy of letter with district and/or site permission j. Methods of maintaining confidentiality (coding, etc.) k. Method of securing data (hard copies locked, electronic data password protected, etc.) 4-E.4. What is the request for review process when the research is a cooperative project involving other institutions in addition to Harding? a. With the approval of the VPAA and the Harding IRB, a researcher at Harding participating in a cooperative project may request in writing to (i) enter into a joint review arrangement between Harding and the other institution(s), (ii) rely upon the review of another qualified IRB, or (iii) make similar arrangements for avoiding duplication of effort [ ]. b. Such a request must be submitted in writing to the IRB administrator and requires Board approval. 23

29 F. Informed Consent 4-F.1. What are the general requirements for informed consent? a. No investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative: 1. An investigator shall seek such consent only under circumstances that (i) provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate, and (ii) that minimize the possibility of coercion or undue influence. 2. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. 3. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence [ ]. 4-F.2. What information must be provided to subjects to ensure compliance with informed consent requirements? a. In seeking informed consent the following information shall be provided to each subject [ (a)]: 1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; 2. A description of any reasonably foreseeable risks or discomforts to the subject; 3. A description of any benefits to the subject or to others which may reasonably be expected from the research; 4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; 5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; 24